Mylan set to sell Nuvigil generic

April 30th, 2012

PITTSBURGH – Mylan Inc. has entered into an agreement with Teva that settles pending patent litigation related to Nuvigil (armodafinil), a medication for sleep disorders.

Mylan said Monday that the settlement enables it to begin selling generic versions of 50-mg, 150-mg and 250-mg armodafinil tablets under license starting in June 2016, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed.

Mylan reported that it was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the Food and Drug Administration for armodafinil tablets in those dosages and expects to be entitled to 180 days of generic market exclusivity.

Indicated to improve wakefulness, armodafinil tablets are used to treat excessive sleepiness from sleep apnea, narcolepsy or shift work sleep disorder.

The product had total U.S. sales of $296 million in 2011, according to IMS Health data cited by Mylan.